- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04504617
Nutrition Education Intervention to Enhance Complementary Feeding Practices Among Infants in Southern Ethiopia
A Theory-based Nutrition Education Intervention to Enhance Complementary Feeding Practices Among Young Children in Southern Ethiopia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Elegibility criteria: residents that have lived in Arsi Negele, Wondo Genet, and Dale districts for at least one year, households that have children between 6 and 23 months of age, households where the mother is permanently presents, and households that speak sidamo or oromio.
Exclusion criteria: residents that have lived in Arsi Negele, Wondo Genet, and Dale districts for less than one year, households that have children under 6 months or above 23 months of age, households where the mother is not present, and households that do not speak sidamo.
Outcomes of this study are child feeding practices knowledge, attitudes, dietary diversity score, meal frequency score, adequacy diet score, continuing breastfeeding, maternal dietary diversity, and prevalence of stunting, wasting, and underweight.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Southern Nations, Nationalities, And Peoples' Region
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Awassa, Southern Nations, Nationalities, And Peoples' Region, Ethiopia
- Hawassa University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Infant that live in a household that has reside in Arsi Negele, Wondo Genet, and Dale districts for at least one year
- Infants that are within the age of 6 to 23 months at the time of the recruitment
- Infants that live in households where the mother is permanently present
- Infants that live in a household where the mother speaks sidamo or oromio.
Exclusion Criteria:
- Infants that live in a household that has reside in Arsi Negele, Wondo Genet, and Dale districts for less than one year
- Infants that are under 6 months or above 23 months of age at the time of the recruitment
- Infants that live in households where the mother is not present
- Infants that live in households where the mother does not speak sidamo or oromio
- Infants that have an illness that require a special nutrition treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention Group
This group will consist of six kebeles with a total of 90 pairs of mothers and their children that will receive the nutrition education intervention to enhance complementary feeding practices first.
The six lessons will be delivered in a period of 6 weeks.
Before the intervention this groups will be assessed with the baseline assessment.
After the intervention, this group will be assessed in three time points (post-intervention, follow-up 1 and follow-up 2).
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The intervention consist of a six-week nutrition education intervention developed following the DESIGN procedure and the Socio-Cognitive Theory.
The intervention consisted of six three-hour weekly sessions that covered topics such as 1) importance and benefits of exclusive and continuing breastfeeding; 2) nutrition for lactating mothers; 3) importance and benefits of complementary feeding practices; 4) risks for starting complementary feeding too early or too late; 5) complementary feeding practices for each age group (6-8, 9-11, and 12-24); 6) importance and benefits of dietary diversity; 7) importance of animal-source foods; 8) importance and benefits of following water, sanitation, and hygiene practices; 9) food safety practices when preparing meals; and 10) the recommended hand-washing protocol.
Each lesson was designed to provide a lecture, a discussion using counseling cards, a cooking demonstration with tasting session, and key messages.
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Active Comparator: Delayed Intervention Group
This arm will consist of the six kebeles with a total of 90 pairs of mothers and their children that will not receive the intervention immediately.
This group will first complete the baseline and the second assessment.
After the second assessment, this group will receive the nutrition education intervention to enhance complementary feeding practices.
After the intervention, this group will be assessed in two additional time points (post-intervention and follow-up 1).
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The intervention consist of a six-week nutrition education intervention developed following the DESIGN procedure and the Socio-Cognitive Theory.
The intervention consisted of six three-hour weekly sessions that covered topics such as 1) importance and benefits of exclusive and continuing breastfeeding; 2) nutrition for lactating mothers; 3) importance and benefits of complementary feeding practices; 4) risks for starting complementary feeding too early or too late; 5) complementary feeding practices for each age group (6-8, 9-11, and 12-24); 6) importance and benefits of dietary diversity; 7) importance of animal-source foods; 8) importance and benefits of following water, sanitation, and hygiene practices; 9) food safety practices when preparing meals; and 10) the recommended hand-washing protocol.
Each lesson was designed to provide a lecture, a discussion using counseling cards, a cooking demonstration with tasting session, and key messages.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Dietary diversity score
Time Frame: Six weeks
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The dietary diversity score will be measured using the population indicator of minimum dietary diversity score for children aged 6 to 23 months designed by The Who.
This measurement assess the consumption of seven food groups through seven yes-no questions.
The food groups that are assessed are the following: 1) grains, roots and tubers; 2) legumes and nuts; 3) dairy products (milk, yogurt, cheese); 4) flesh foods (meat, fish, poultry, and organ meats); 5) eggs; 6) vitamin A rich fruit and vegetables; and 7) other fruits and vegetables.
The total dietary diversity score for each participant will be the sum of the food groups that were responded with a yes answer.
The maximum score possible is seven.
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Six weeks
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Meal frequency
Time Frame: Six weeks
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The meal frequency of children will be measured using a question that forms part of the Infant Young and Child Feeding Practices questionnaire provided by the WHO.
This question assess the number of times that a baby had meals or snacks, other than liquids, through a multiple answer questions.
The participating mother has the option to select the meal frequency from one to six times.
The average meal frequency will be calculated for those breastfed and non-breastfed children.
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Six weeks
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Acceptable diet score
Time Frame: Six weeks
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This is an indicator that measures the proportion of children aged 6 to 23 months of age who receive the minimum feeding frequency and minimum dietary diversity.
The acceptable diet score will be calculated using the proportion of children that meet the minimum dietary diversity and the minimum meal frequency divided by the total number of children.
This score will be calculated for breastfed and non-breastfed children.
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Six weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Child feeding knowledge score
Time Frame: six weeks
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The child feeding knowledge score will be assessed using the questions obtained from the FAO Guidelines for assessing nutritional-related knowledge, attitudes, and practices.
The section of knowledge includes 7 open-ended questions in which the data collector will ask an open-ended question to the mother and the mother will have to provide a short answer in her own words.
The knowledge score per participant will be calculated based on the number of correct answers provided and an average score of participants will be calculated.
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six weeks
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Child feeding maternal attitude score
Time Frame: six weeks
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The child feeding maternal attitude score will be assessed using the questions obtained from the FAO Guidelines for assessing nutritional-related knowledge, attitudes, and practices.
The section of attitudes includes 7 three-point Likert scale questions.
These questions will assess self-confidence, perceived benefits and barriers for providing diversity foods, frequently meals, and continued breastfeeding for their children aged 6 to 23 months.
Responses will be codified to calculate an attitude score per participant.
Responses will be codified in the following way: "no confident", "not good" and "challenging" as one; "ok/so-so", "you're not sure", and so-so as two; and "good" and "not challenging" as three.
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six weeks
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Maternal dietary diversity score
Time Frame: six weeks
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The dietary diversity score will be measured using the Minimum Dietary Diversity for Women (MDD-W).
This measurement assess the consumption of 10 food groups through 17 yes-no questions.
The food groups that are assessed are the following: 1) grains, white roots, tubers, and plantains; 2) pulses (beans, peas, and lentils); 3) nuts and seeds; 4) dairy; 5) meat, poultry and fish; 6) eggs; 7) dark green leafy vegetables; 8) other vitamin-A rich fruits and vegetables; 9) other vegetables; and 10) other foods.
The total dietary diversity score for each participant will be the sum of the food groups that were responded with a yes answer.
The maximum score possible is ten.
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six weeks
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Nutritional status
Time Frame: six weeks
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WHO Anthro software will be utilized to calculate weight-for-height z-score (WHZ), height-for-age z-score (HAZ), and weight-for-age z-score (WAZ).
Then those children that have a -2 standard deviation in their WHZ, HAZ, and WAZ will be categorized as having wasting, stunting, or underweight.
The prevalence of these nutritional status categories will be compared before and after the intervention.
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six weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mary W Murimi, PhD, Texas Tech University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB2019-664
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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